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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K103458
Device Name VIEWPOINT 6
Applicant
GE HEALTHCARE
3000 NORTH GRANDVIEW BLVD
#W450
WAUKESHA,  WI  53188
Applicant Contact NICOLE LANDREVILLE
Correspondent
GE HEALTHCARE
3000 NORTH GRANDVIEW BLVD
#W450
WAUKESHA,  WI  53188
Correspondent Contact NICOLE LANDREVILLE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/23/2010
Decision Date 03/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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